Principal Clinical Pharmacologist

Regeneron Pharmaceuticals, Inc; Cambourne; On-site; GBP 135,000 - 179,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Principal Scientist in Clinical Pharmacology within the Pharmacometrics (PMx) group. The role reports to the Senior Group Director and provides strategic and scientific expertise for GM clinical programs.

You will contribute to PMx deliverables across multiple programs and guide longer-term development strategies. The person will conduct or oversee PMx analysis plans, draft study protocols, and collaborate with cross-functional teams to accelerate

Qualifications

• PhD (example Pharmacometrics, Biology, Pharmacology, Engineering), PharmD or MD required.
• 6+ years of experience in clinical pharmacology.
• Strong communication skills to engage cross-functionally.

Responsibilities

• Develop and maintain strategic CP development plans for assigned programs with SGD supervision.
• Provide CP SME presentations to Clinical Study Team/Development Team and Senior Management with SGD supervision.
• Collaborate with Pre-clinical PK/PD and research teams to model human PK/PD for faster clinical decisions.
• Draft and finalize clinical study protocols and analysis plans; review clinical pharmacology reports.
• Coordinate with Medical Writing to include PK/PD sections in study reports.
• Support CP regulatory documents and health authority communications with SGD supervision.
• Represent CP at pre-IND, Type C, preBLA, and other health authority meetings.
• Work with Quantitative Pharmacology to deliver analyses and technical reports for development plans.
• Actively publish work in scientific literature.

Skills

Clinical pharmacology

Cross-functional communication

PK/PD knowledge

Research collaboration

Education

PhD / PharmD / MD in relevant field

Job description

Build Our Future Together

We are looking for a Principal Scientist, Clinical Pharmacology in our Pharmacometrics (PMx) group. The position will report to the Senior Group Director (SGD) within Clinical Pharmacology (CP) in the General Medicine (GM) group. This person will represent Clinical Pharmacology on project teams to provide strategic and scientific expertise to support new and on-going GM clinical programs. This individual is expected to provide significant contributions to PMx deliverables for multiple programs to support the strategies for each program. In addition, this person will prospectively contribute to longer-term development strategies executed over the course of multiple non-clinical experiments, clinical studies and PMx analyses. This person conducts or otherwise oversees the development of PMx analysis plans.

When & where:

• Work Location: Tarrytown, NY, Warren, NJ or Cambridge, MA
• Work model/flexibility: 4 days per week on site
  

Discover your role:

• Develop and maintain comprehensive strategic CP development plans for assigned programs with SGD supervision
• Provide CP subject matter expertise and presentations to the Clinical Study Team/ Development Team and Senior Management/Governance meetings with SGD supervision
• Collaborate and assist the Pre-clinical PK/PD Team and research teams to characterize preclinical PK/PD for prediction human PK/PD to accelerate clinical studies and achieve business goals
• Assist in drafting and finalization of clinical study protocols and study analysis plans as well as draft, finalize, and/or review clinical pharmacology reports
• Collaborate with the Medical Writing Team to incorporate PK/PD sections into clinical study reports
• Provide CP support of regulatory documents, communications, and presentations (eg, IND, health authority queries, preparation of BLA summary sections, addressing review inquiries) with SGD supervision
• Represent CP at pre-IND, Type C, preBLA, and other health authority meetings with SGD supervision
• Work closely with Quantitative Pharmacology to develop quantitative strategies and to deliver analyses and technical reports to support strategic development plans
• Actively publish work in scientific literature

This role requires:

• PhD (example Pharmacometrics, Biology, Pharmacology, Engineering), PharmD, MD
• 6+ years of experience in clinical pharmacology
• Strong communications skills to actively engage colleagues cross-functionally at all levels of the organization
• Innovative and flexible mindset, keen scientific interest and solid science background are required.